Safety, Effectiveness Of Medical Devices To Be Regulated

KAJANG, May 9 (Bernama) -- Legislation is being drafted to ensure the safety and effectiveness of medical devices sold and used in the country, Health Minister Datuk Dr Chua Soi Lek said.
He said the Medical Devices Bill 2006 was in the final stage of drafting and might be tabled in Parliament at the end of the year.
If adopted, the legislation would allow medical practitioners three years to learn and understand the terms and regulations before it was enforced, he said in his speech to open a syringe manufacturing plant owned by Muzamal Sdn Bhd at Balakong, here Tuesday.
He said a framework was being prepared to determine the method of regulating the use of medical devices based on recommendations by international bodies like the Global Harmonisation Task Force.
"Development of a regulating programme based on international standards and compatible with the system practised by Malaysia's trading partners will reduce trade obstacles and enable Malaysian-made medical devices to compete and penetrate global markets," he said.
Dr Chua said the ministry had introduced an initial measure to regulate medical devices by implementing an online system of Voluntary Registration for Medical Devices Establishment (MeDVER) since Jan 12 to enable companies to obtain information and advisory service to prepare for the enforcement of the new law.
He said 154 manufacturers, importers and distributors of medical devices had registered with MeDVER.
At a news conference later, Dr Chua said the medical devices industry recorded more than RM4.6 billion in export during the first 11 months of last year.